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新GSP认证中部份
 
(5)收货员操作界面,应有物流的承运信息,如在途时间、承运时间。承运信息由采购订单传递到收货员界面。 
(6)冷链品种的收货时间控制、温湿度控制。 
(7)信息部介绍、演示系统的基础数据,如品种分类,管控点的范围包括上下游经营范围控制,委托书时效,质保协议时

效、资质时效,系统具备药品过期的拦截功能,提示功能。 
(8)采购订单界面,承运信息:承运方式,承运单位、发运地点、在途时限、启动时间、运输方式。收货员勾兑采购订单

,核实承运信息。


(9)体系文件的操作流程应与计算机流程相符。 
(10)基础数据,包括品种信息、供应商信息,质管部负责录入、更新。 
(11)经营数据的修改,应作风险评估,修改在质管                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                部监督下进行。 
(12)岗位操作权限设置,由质管部授权,离职、新增人员,进入系统应重新授权。根据岗位授权设置相应的权限,如收货

员无分配货位号的权限(验收员权限),关闭与收货员岗位无关的查询模块。 
7、温湿度监控系统的布点。质量负责人、质管部、仓储负责人需了解布点方案、布点的要求、设备的校验。 
(1)了解校验报告、校验方案。 
(2)一般情况下,温湿度系统不与ERP对接。 
(3)冷链药品的验证。验证报告,验证实施时间应与图表时间一致。对验证过程的拍照取证。验证项目按类别进行,完成

一个项目后再进行另一个项目的验证,不能穿叉进行。 
冷链数据偏差纠正。 
冷藏车厢内划线,限高堆放。 
开门作业的时间限制。应有开门作业的说明流程 
8、方针目标的分解。包括分解项目、内容、措施、实施人员、实施时间。 
比如,项目:基础数据管理,质量目标:准确率百分百。采取措施:首营企业信息录入后核对百分百,及时更新百分百。 
比如经营数据修改的合法性百分百,采取措施:数据修改作风险评估率100%,数据修改的审核率百分百,修改的监督率百

分百。 
9、风险评估。各个部门寻找风险点,质管部汇总。评估方式可以用文字形式评估,或报表形式。评估内容应包括评估项目

、评估要求、潜在的风险,风险后果,风险严重性,风险原因,控制预防风险的措施、责任人。 
举例:计算机管控的风险,系统设计的功能不全面,对某个环节管控失效。原因分析:人员不了解新版的要求、系统功能

设计未经相关部门审核、审核人不熟悉系统。 

 
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